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Pharmacovigilance responsibilities of medicine sponsors
Australian recommendations and requirements
Pharmacovigilance and the law
Your pharmacovigilance responsibilities outlined in this guidance is underpinned by legislation.
- Under subsection 28(5)(e) of the Therapeutic Goods Act 1989 and Regulation 15A of the Therapeutic Goods Regulations 1990, you must comply with any reporting requirements that have been prescribed as a condition of registering or listing your therapeutic good in the ARTG.
- Subsection 28(2B) and 28(3) of the Act allows us to impose certain conditions of listing or registration on a therapeutic good when it is entered in the ARTG or at any time while it remains on the ARTG, including when it is suspended (see subsection 29G of the Act). We can use this subsection to require you to submit Periodic Safety Update Reports (PSURs).
- Under Subsection 28(5)(ca) of the Act, you must comply with any record-keeping requirements that are prescribed.
- Under Sections 29A and 29AA of the Act, you must advise the TGA in writing as soon as you become aware of information that:
- contradicts information you have already furnished under the Act
- indicates that using the registered or listed medicine in accordance with recommendations for its use may have an unintended harmful effect
- indicates the registered or listed medicine, when used in accordance with the recommendations for its use, may not be as effective as information submitted or relied on at the time of listing or registration would suggest
- indicates the quality, safety or efficacy of the registered or listed medicine is unacceptable.
- Under Subsection 31(1) of the Act, you are required to provide information or documents relating to the safety, efficacy and quality of the goods in the time and format specified by us.
- You must abide by the Australian Privacy Principles set out in the Privacy Act 1988 and any applicable state and territory privacy legislation when you collect, use or disclose personal information.
Our requirements do not override any applicable privacy laws. Any personal information you collect may be disclosed by consent or where the disclosure is required by, or authorised under, a law (e.g. under section 61 of the Act). Where a report relates to vaccine events, the patient or reporter's personal information may be disclosed to state and territory health agencies under subsection 61(3) of the Act.
General privacy information is available on our website.
Failure to comply with requirements
- Under subsections 29D(1)(b) and 30(2)(c) of the Act we can cancel or suspend medicines from the ARTG for refusing or failing to comply with a condition of registration or listing.
- Section 21A of the Act specifies the grounds for prosecuting offences related to not complying with conditions of registration or listing.
- Section 29A of the Act specifies the grounds for prosecuting offences related to failing to notify us of adverse reactions of your medicine.